FDAFDA · Food and drugs·Recall number Z-1092-2022
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Published May 25, 2022 · Recall initiated: April 5, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Luminex Corporation
- Distributor
- US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
- Lot
- Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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